Eliciting a blood sample

ABSTRACT

Apparatus for eliciting a blood sample comprises: a housing; a shaft mounted within the housing; an aperture in the housing, the aperture being configured to receive a part of a user; a member rotatably mounted on the shaft; a lancet protruding from one position at an edge of the member, and a blood collection part located at a second, different position at the edge of the member. The apparatus is configured such that: when the member is in a first rotational position the lancet is shielded by the housing, when the member is in a second rotational position the lancet is operable to lance the part of the user received at the aperture, and when the member is in a third rotational position the blood collection part is presented such as to receive blood from the part of the user received at the aperture.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a U.S. national phase of International ApplicationNo. PCT/EP2011/061537 filed on Jul. 7, 2011, which claims priority toEuropean Patent Application No. 10168955.2 filed Jul. 8, 2010, thedisclosures of which are incorporated herein by reference in theirentirety.

FIELD OF THE INVENTION

This invention relates to method and apparatus for eliciting a bloodsample, and to apparatus including a lancet and a blood collection part.

BACKGROUND

Diabetes sufferers may be provided with quantities of insulin, forinstance by injection, sometimes a number of times daily. The quantityof insulin that is appropriate depends on the person's blood glucoselevel, so blood glucose level measurement can also occur a number oftimes daily.

Blood glucose level measurement typically is a multi stage process. Thefirst is lancing, in which a lancet, or needle, is used to pierce theskin of a user, for example on the end or side of a finger. Once asuitable amount of blood has been produced, a sample is taken on atesting strip. A person may need to squeeze their finger in order tocause sufficient blood to be expelled. Sometimes lancing needs to bereperformed. The testing strip then is provided to a meter, typically anelectronic meter, which analyses the sample, for example by determininga parameter (e.g. an electrochemical potential or voltage, resultingfrom a chemical reaction between the blood sample and an enzyme presentin the testing strip), and provides a blood glucose measurement result.This measurement is then used to determine an amount of insulin to beconsumed by the person.

SUMMARY

According to a first aspect of the invention there is provided apparatusfor eliciting a blood sample, the apparatus comprising:

a housing;

a shaft mounted within the housing;

an aperture in the housing, the aperture being configured to receive apart of a user;

a member rotatably mounted on the shaft;

a lancet protruding from one position at an edge of the member,

a blood collection part located at a second, different position at theedge of the member,

wherein the apparatus is configured such that:

when the member is in a first rotational position the lancet is shieldedby the housing,

when the member is in a second rotational position the lancet isoperable to lance the part of the user received at the aperture, and

when the member is in a third rotational position the blood collectionpart is presented such as to receive blood from the part of the userreceived at the aperture.

Apparatus this constructed can provide collection of a blood sample at ablood collection part, for instance for blood parameter arrangement,whilst being of relatively simple construction. Moreover, this can beachieved whilst requiring relatively little from the user. Inparticular, the apparatus can allow lancing and blood collection withoutthe user being required to move (for instance) their digit from theaperture. The process for measuring a blood parameter can thus beconsiderably simpler for a user than is the case with conventional,multi-stage arrangements.

The member may further comprise at least two electrical contact pointsconnected to the blood collection part for communication with a meterfor determining a parameter of blood chemistry.

This can allow a meter and associated terminals to be used to performblood parameter measurements from plural different members. In this way,a used member does not need to be re-used, but the meter can be re-used.

The blood collection part may include a wicking or absorbent part and ananalyte measurement part.

This can result in a blood sample being received at the analytemeasurement part without requiring any specific action from the user. Inparticular, this can be achieved without requiring the user to do morethan maintain their (for example) digit in the aperture after lancing.

The apparatus may be configured to maintain the member at the thirdrotational position until it is determined that a quantity of bloodcollected at the blood collection part is sufficient to allow a bloodchemistry measurement to be made.

This can help to maximise the probability of a successful bloodparameter measurement, and in turn can reduce the likelihood ofre-lancing being required. Blood chemistry measurement may or may not becompleted at the time of the determination. The determination that thequantity of blood collected at the blood collection part is sufficientto allow a blood chemistry measurement to be made can be communicated tothe user in any suitable way. For instance, rotation of the member awayfrom the third rotational position can indicate to the user that theblood quantity is sufficient. Alternatively, the apparatus maycommunicate in some different way, for instance through an audioannouncement such as a tone or beep.

The member may be provided with a milking part between the first andsecond locations on the edge of the member.

This can help to ensure that a sufficient quantity of blood isextracted. This can be achieved without any action by the user, and theuser may need only to maintain their (for example) digit in theaperture.

According to a second aspect of the invention there is provided a methodof eliciting a blood sample, the method comprising:

providing a housing, a shaft mounted within the housing, an aperture inthe housing, the aperture being configured to receive a part of a user,a member rotatably mounted on the shaft, a lancet protruding from oneposition at an edge of the member, and a blood collection part locatedat a second, different position at the edge of the disc-like member;

commencing in a first rotational position in which the lancet isshielded by the housing;

rotating the member to a second rotational position in which the lancetis operable to lance the part of the user received at the aperture; and

rotating the member to a third rotational position in which the bloodcollection part is presented such as to receive blood from the part ofthe user received at the aperture.

According to a third aspect of the invention there is provided apparatuscomprising:

a housing;

a shaft, the shaft being mounted within the housing;

an aperture, the aperture being located in the housing, the aperturebeing configured to receive a part of a user;

at least one member, each of said at least one member being mounted onthe shaft so as to be rotatable thereon, and wherein each of said atleast one member:

includes an edge;

includes a lancet, the lancet being arranged to protrude from a firstposition at said edge of said at least one member; and

includes a blood collection part, the blood collection part beinglocated at a second position at said edge of said member,

wherein the apparatus is configured such that:

when the member is in a first rotational position, the lancet isseparated from the aperture so as to be shielded by the housing,

when the member is in a second rotational position, the lancet isoperable to lance the part of the user received at the aperture, and

when the member is in a third rotational position, the blood collectionpart is presented such as to receive blood from the part of the userreceived at the aperture.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the invention will now be described, by way of exampleonly, with reference to the accompanying drawings, in which:

FIG. 1 is a perspective view of a blood glucose meter (BGM) according toaspects of the invention.

FIG. 2 is a perspective view of the BGM of FIG. 1 with a portion shownas transparent, so as to allow features inside a housing to be seen;

FIG. 3 is the same as FIG. 2 although a lid portion is shown as beingremoved;

FIG. 4 is the same as FIG. 3, although a cartridge is shown as partlyremoved;

FIG. 5 illustrates components of one embodiment the BGM of FIG. 1;

FIG. 6 is a perspective view of components of the BGM of FIG. 5 but witha hollow cylindrical housing part shown as transparent;

FIG. 7 is a perspective view of a test disc member forming part of theBGM of FIGS. 1 and 5;

FIG. 8 is an underneath perspective view of the test disc member of FIG.7;

FIGS. 9 to 12 illustrate the BGM of FIGS. 5 to 7 at different stages ofa blood collection sample process;

FIG. 13 is a perspective view of components of the BGM of FIG. 1;

FIG. 14 is the same as FIG. 13, although with a hollow cylindricalhousing part not shown;

FIG. 15 is the same as FIG. 14 although with a swing arm located in adifferent position;

FIG. 16 illustrates components of a second embodiment of the BGM of FIG.1 in a perspective view;

FIG. 17 illustrates a test disc member forming part of the FIG. 16embodiment;

FIGS. 18 to 21 illustrate the embodiment of the BGM of FIG. 16 atdifferent phases of operation;

FIG. 22 is an alternative embodiment of a test disc member;

FIG. 23 is a flowchart illustrating operation of the first embodiment ofthe BGM of FIG. 1; and

FIG. 24 is a flowchart illustrating operation of the second embodimentof the BGM of FIG. 1.

DETAILED DESCRIPTION

A blood glucose meter (BGM) 100 is shown in FIG. 1. The BGM 100 is shownin a perspective view. The BGM 100 has a generally flat base, that isnot visible in the figure. The BGM 100 is approximately as tall as it islong, and its width is approximately one-third of its height.

On one side face of the BGM are provided first, second and third inputs101, 102, 103. These may take the form of push-switches or touchsensitive transducers, for instance. Also provided on the side of theBGM next to the input devices 101 to 103 is a display 104. This may takeany suitable form, for instance a liquid crystal display (LCD), e-inketc. In use, a user may control the BGM 100 using the input devices 101to 103 and may be provided with information by the BGM through thedisplay 104.

Located at a front face of the BGM 100 is an aperture 105. The aperture105 is located at approximately half of the height of the BGM. Theaperture 105 is configured such as to be able to receive a part of auser's body, for the purpose of extracting a blood sample therefrom. Forinstance, the aperture 105 may be dimensioned so as to receive an end ora side part of a finger or thumb, or may be dimensioned so as to receivea side of a user's hand or a pinch of skin from a user's arm. Theaperture may be rectangular in shape. Its edges may be bevelled, so asto guide a user's digit into a specific location.

The aperture 105 is provided in the side of a cartridge 106. Thecartridge has a generally cylindrical form, and is arranged verticallyin the BGM 100.

In particular, the BGM includes a first housing part 107. The firsthousing part 107 forms the base, left and right side face and the rearface of the BGM 100. On the front face of the BGM 100, the first housingpart 107 also comprises the lowermost part of the side face. A fixed lidpart 108 is attached to the first housing part 107. The fixed lid part108 comprises most of the top surface of the BGM 100. A removable lidpart 109 comprises the remaining part of the top surface of the BGM 100.The removable lid part is disposed above the cartridge 106 at the frontface of the BGM 100.

The first housing part 107 is configured such as to provide an elongateaperture 110 at the front face of the BGM 100. The elongate aperture 110may extend for most of the height of the front face of the BGM 100. Theelongate aperture 110 is defined at the uppermost part by the removablelid part 109 and is defined by the first housing part 107 at the right,left and bottom. The BGM 100 is arranged such that the cartridge 106occupies the whole of the area of the elongate aperture 110. A slidableor pivotable door in the housing part 107 of the BGM 100 may cover allor a part of the elongate aperture 110 when the BGM is not in use. Thedoor may cover at least the aperture 105, such as to prevent the ingressof dirt and other potential contaminants into the aperture 105

The cartridge 106 is more clearly visible in FIG. 2. FIG. 2 shows thesame view as FIG. 1, although the removable lid part 109 and the firsthousing part 107 are shown in wire frame. As can be seen from FIG. 2,the cartridge 106 has a generally cylindrical form, and is arrangedvertically. The diameter of the cartridge 106 is greater than the widthof the aperture 110 by a factor for instance of between 5 and 50%. Thecartridge 106 has a length that is between 3 or 4 times its diameter.

In FIG. 3, the removable lid part 109 is shown as having been removedfrom the BGM 100. The first housing part 107, the fixed lid part 108 andthe removable lid part 109 are configured such that when the removablelid part is in place on the BGM the cartridge 106 is retained bymechanical interaction between the three components but is removable bya user. The exact way in which the removable lid part 109 is releasedfrom the BGM 100 is not critical and is not described in detail here.

The removable lid part 109 is configured such that when removed from theBGM 100 the cartridge 106 is able to be extracted from the BGM by movingit vertically along its axis. In FIG. 4, the cartridge 106 is shown asbeing partly removed from the BGM 100. When fully removed, the elongateaperture 110 reveals a cavity in the BGM 100. A replacement cartridgecan then be introduced into the BGM 100 in the opposite manner to whichthe old cartridge 106 was removed. Once located at the bottom of thecavity in the BGM, the new cartridge 106 is partly surrounded by thefirst housing part 107. Once the removable lid part 109 has beenreplaced, to the position shown in FIG. 1, the cartridge 106 is retainedin place by the action of the first housing part 107 and the removablelid part 109. The aperture 105 in the cartridge 106 is presented at thefront face of the BGM 100, in the same way as shown in FIG. 1. Thecartridge 106 and the cavity which receives the cartridge may have akeying feature, such as a protrusion and a groove, a non circulardiameter, or the like. Thus, when the cartridge 106 is fully inserted,the aperture 105 is in a fixed position to the elongate aperture 110,for example in a centred position as shown in FIG. 1.

FIG. 5 shows a subsystem 200 of the blood glucose meter 100. Thesubsystem 200 includes the cartridge 106, a drive wheel 201 and a drivebelt 202.

In FIG. 5, the cartridge shown as having a hollow cylindrical housingpart 203, which constitutes part of a housing. The aperture 105 isformed in the hollow cylindrical housing part 203. Coaxial with thehollow cylindrical part 203 is an elongate shaft 204, only the top partof which is illustrated in FIG. 5. The length of the shaft 204 is suchthat its uppermost end is slightly below the uppermost end of the hollowcylindrical housing part 203. As will be described below, the shaft 204is mechanically coupled with the drive belt 202 so as to be rotatable byrotation of the drive wheel 201.

Formed with the inner surface of the hollow cylindrical housing part 203are first and second guide members 205, 206. In FIG. 5, it can be seenthat the first and second guide members 205, 206 have a generallytriangular cross section. One side of the triangular cross section ofthe first and second guide members 205, 206 is integral with the innersurface of the hollow cylindrical housing part 203, with a point of thetriangular cross section extending towards the centre of the cartridge106. A part of the length of the first guide member 205 is visible inFIG. 5, but only the uppermost surface of the second guide member 206 isvisible in that figure.

FIG. 5 also shows some electronic components that form parts of theblood glucose meter 100. These components are provided within thehousing 107 but do not form part of the cartridge 106.

A bus 211 is arranged to connect a number of components including amicroprocessor 212, random access memory (RAM) 213, read-only memory(ROM) 214, a keys interface 215, a display driver 216, an analyteinterface circuit 219 and a motor interface 217. All of these componentsare powered by a battery 218, which may take any suitable form.

Stored in the ROM 214 is software and firmware that governs operation ofthe blood glucose meter 100. The software/firmware is executed by themicroprocessor 212 using the RAM 213. The software/firmware stored inthe ROM 214 is operable to operate the blood glucose meter 100 such asto allow control by a user through the keys or input devices 101 to 103,as detected by the keys interface 215. A blood glucose measurement andother information is provided on the display 104 at suitable times byoperation of the software/firmware and the microprocessor 212 throughthe display driver 216.

The motor interface 217 allows the microprocessor 212, according to thesoftware/firmware stored in the ROM 214, to control the motor that iscoupled to the drive wheel 201, and any other motors that are includedin the blood glucose meter 100 (as will be described below).

The analyte interface circuit 219 is operable to provide electricalsignals with certain voltages to the electrical contact terminals 401,and thus the contact pads 318 and thus the analyte measuring part 316,and to measure parameters of signals such as to allow the microprocessor212 to determine a blood glucose level of a blood sample.

FIG. 6 shows the drive wheel 201 and cartridge 106 of FIG. 5 with thehollow cylindrical housing part 203 shown in wire frame, so as to revealcomponents internal to it, and in that the electronic components areomitted. In FIG. 6, a third guide member 207 is visible. As can be seenfrom this figure, the first and second guide members 205, 206 arelocated only in the uppermost half of the length of the cartridge 106,and the third guide member 207 is located only in the lowermost half ofthe cartridge 106. The first, second and third guide members 205 to 207are distributed around the circumference of the hollow cylindricalhousing part 203. In particular, the first and second guide members 205,206 are located at approximately 100 to 160 degrees from one another.The third guide member 207 is located approximately 60 to 130 degreesfrom each of the first and second guide members 205, 206.

Mounted on the shaft 204 are a plurality of members, three of which areshown in FIGS. 6 as 208, 209 and 210 respectively. The members 208 to210 will hereafter be referred to as test disc members. Each of the testdisc members 208 to 210 is substantially the same.

One test disc member 208 is shown in some detail in FIG. 7. The testdisc member 208 has a generally circular shape, although on one side anotch 301 is formed and on another side a cutaway portion 302 isprovided. The cutaway portion constitutes a milking portion, and will bedescribed in more detail below.

The test disc member 208 includes an uppermost surface 303, a lowermostsurface 304, which is shown in FIG. 8, and a disc edge 305. The diameterof the test disc member 208 is between 15 and 25 millimetres, forinstance 20 millimetres. The thickness of the disc, which is equal tothe height of the disc edge 305, is between 0.5 millimetres and 1millimetre. FIG. 8 shows the test disc member 208 from the underside. Assuch, the lower surface 304 is visible and the upper surface 303 is notvisible. The test disc member 208 will now be described with referenceto FIGS. 7 and 8.

A hole 306 is formed at the centre of the test disc member 208. The hole306 comprises two main parts. A circular part is centred on the testdisc member 208 and has a diameter equal to or slightly larger than theexternal diameter of the shaft 204. A drive notch 307 abuts the circularpart of the hole 306 and includes edges that are able to be engaged by adrive dog.

A drive dog 320 (visible in part in FIG. 9 and more fully in FIG. 10) isformed on the shaft 204. The drive dog 320 is engaged with the drivenotch 307 in the hole 306 of the test disc member 208. This engagementallows rotation of the shaft 204 to result in rotation of the test discmember 208.

On the underside of the test disc member 208 is provided a spacer member308. The spacer member 308 comprises a slice of a hollow cylinder. Thecylinder is centred on the centre of the test disc member 208. The innerdiameter of the spacer member 308 is selected such that the hole 306does not overlap with the spacer member 308. The outer diameter of thespacer member 308 is only slightly greater than the inner diameter, sothe spacer member 308 has little thickness. The height of the spacermember 308 is between 0.5 and 1 millimetre. When plural test discmembers are stacked together, the spacer member 308 provides separationbetween the upper surface 303 of one test disc member and the lowersurface 304 of the test disc member that is directly above it. Theseparation is determined by the height of the spacer member 308.

Referring again to FIG. 7, a lancet 309 is shown protruding from thedisc edge 305. The lancet 309 is provided in the cutaway portion 302. Afirst end of the lancet 309 is embedded within the material of the testdisc member 208, and a second end is provided with a sharp point andextends outwardly. The lancet 309 extends at an angle between 30 and 60degrees from a radius line of the test disc member 208 at the positionwhere the end of the lancet 309 is embedded in the test disc member. Thesecond end of the lancet 309 is located at or just outside acircumference 311 of the test disc member 208. The circumference 311 isshown as a dotted line in FIG. 7 because it is virtual, instead oftangible. The lancet 309 extends from the disc edge 305 at a firstposition 312 on the disc edge. The first position 312 is close to asecond position 313 at which the cutaway portion 302 starts. The cutawayportion 302 ends at a third position 314. Between the second and thirdpositions 313, 314 opposite to the cutaway portion 302, the disc edge305 generally takes the form of a circle, although the notch 301interrupts that circle.

Located next to the third position 314 is a blood collection part 315.This may take any suitable form. For instance, it may comprise alaminated material. The blood collection portion 315 has the function ofdrawing blood that is in contact with the disc edge 305 at the thirdposition into the test disc member 208 to an blood analyte measuringpart 316, that adjoins the blood collection part 315, for example a partcontaining an enzyme for blood glucose measuring, or the like. Blood maybe drawn through capillary action. The analyte measuring part 316includes an enzyme that reacts chemically with blood in such a way thatblood glucose level can be measured. The analyte measuring part 316 isconnected to first to third contact pads 318 by first to thirdconductive tracks 317. The contact pads 318 and the conductive tracks317 are formed on the upper surface 303 of the test disc member 208. Theanalyte measuring part 316 analyte measuring part 316 also is formed onthe upper surface 303 of the test disc member 208. Some or all of theconductive tracks 317, the contact pads 318 and the analyte measuringpart 316 may be printed onto the upper surface 303 of the test discmember 208. In an alternative embodiment, the test disc member 208 mayhave only 2 contact pads. In yet another embodiment, the test discmember 208 may have more than 3 contact pads, for example, 4 or 5contact pads.

As will be described in detail below, in use a part of a user is firstlypierced by the lancet 309, the part is then milked by the disc edge 305at the cutaway portion 302, and blood then is provided to the analytemeasuring part 316 through the blood collecting portion 315. A measuringcircuit connected to the analyte measuring part 316 by way of theconductive tracks 317 and the contact pads 318 then is able to determinea blood glucose level of the user. The level then is displayed on thedisplay 104.

Operation will now be described with reference to the figures.

As shown in FIG. 6, the test disc members 208 to 210 commence at thesame orientation. Here, the first test disc member 208 is uppermost. Thethird guide member 207 is located in the notch 301 of the lowermost testdisc members 209, 210. The notch 301 of the first test disc member 208is aligned with the third guide member 207, but is not constrainedthereby. The upper surface 303 of the uppermost test disc member 208 isin contact with a lowermost surface of the first guide member 205. Thelowermost surface of the second guide member 206 is at the same level asthe lowermost end of the first guide member 205. However, the secondguide member 206 coincides with part of the cutaway portion 302 of thefirst test disc member 208 at the orientation of the test disc member208 shown in FIG. 6. As such, there is no contact between the secondguide member 206 and the first test disc member 208 when the first testdisc member is in this position. The test disc members 208 to 210 arebiased in an upwards direction by bias means (not shown), which may be aspring. However, the test disc members 208 to 210 are prevented frommoving upwards within the cartridge 106 by virtue of the contact betweenthe upper surface 303 of the first test member 208 and the lowermost endof the first guide member 205.

At the position shown in FIG. 6, the distal end of the lancet 309 is notco-located with the aperture 105. As such, the lancet 309 is in thisposition not operational. Put another way, the lancet 309 at thisposition is shielded by the hollow cylindrical part 203, whichconstitutes part of the housing.

From the position shown in FIG. 6, the shaft 204 is caused to rotate ina first direction, for example in a clockwise direction, by action ofthe drive wheel 201 and drive belt 202. The drive dog 320 is engagedwith the drive notch 307 in the hole 306 of the test disc member 208,and so allows rotation of the shaft 204 to result in rotation of thetest disc member 208. Rotation brings the lancet 309 in front of theaperture 105. As such, a skin-covered part of a user (hereafter the partwill be referred to as a user's digit, for the sake of convenience) islanced by the lancet 309. This produces a puncture in the skin of thedigit, through which blood can escape. FIG. 9 shows the first test discmember 208 rotated to the position where the lancet 309 is operable tolance the user's digit. The shaft 204 is caused to rotate only by apredetermined amount, the maximum extent of travel of the lancet 309 iscontrolled. The penetration of the lancet 309 in the user's digitdepends on a number of factors, as will be appreciated by the personskilled in the art. The amount of rotation, and thus the depth ofpenetration, may be definable by a user. The penetration depth specifiedby a user may be achieved through software or firmware control ofrotation of the shaft 204. The penetration depth may be defined by theuser for example using one or more of the first, second and third inputs101 to 103. For instance, the first and second inputs 101, 102 may beincrease and decrease respectively, with the third input 103 being aselect or confirm input. The value defining the depth may be stored inmemory. Subsequently, the shaft 204 is controlled to rotate in anopposite direction, for example in an anticlockwise direction. Thiscauses the lancet 309 to be removed from the user's digit, and for thedisc edge 305 at the cutaway portion 302 to rub the user's digit as thetest disc member 208 rotates. At a point in the rotation of the testdisc member 208, the lowermost part of the second guide member 206ceases to coincide with the cutaway portion 302 and so is able to exerta reaction force on the upper surface 303 of the test disc member 208. Ashort time thereafter, the lowermost part of the first guide member 205becomes coincident with the cutaway portion 302, and ceases to contactthe upper surface 303 of the test disc member 208. At this point, it isthe second guide member 206 that prevents the first test disc member 208moving upwards within the cartridge 206.

The test disc member 208 continues to rotate until the blood collectionportion 315 is aligned with the aperture 105. Here, rotation ceases. Atthis location, blood that has been caused to be expelled from the user'sdigit by the lancet 309 and by action of the disc edge 305 on the user'sdigit is caused to be drawn to the analyte measuring part 316 bycapillary action. The blood and the enzyme then react.

At a suitable time, the shaft 204 is caused to be rotated further in theopposite direction, for example in an anticlockwise direction. Here, thetest disc member 208 is caused to be rotated from the position shown inFIG. 10, in which the blood collection portion 315 is coincident withthe aperture 105, to the position shown in FIG. 11. Here, the notch 301is aligned with the second guide member 206. Because at this locationthe first guide member 205 is coincident with the cutaway portion 302 ofthe test disc member 208, neither of the first or second guide members205, 206 prevents upwards movement of the first test disc member 208. Assuch, the first to third disc members 208 to 210 are moved upwards byvirtue of the bias means (not shown).

When the first test disc member 208 moves upwards, between FIGS. 11 and12, the drive dog 320 ceases to cooperate with the drive notch 307 ofthe hole 306 of the first test disc member 208. Before the first testdisc member 208 reaches the position shown in FIG. 12, a lower surfaceof the drive dog 320 contacts the upper surface 303 of the second testdisc member 209. This prevents further upward movement of the secondtest disc member 209, and thus prevents further movement of the testdisc member 210. At this position, the shaft 204 is caused to be rotatedby the drive wheel 201 and the drive belt 202 such that the drive dog320 is coincident with the drive notch 307 of the second test discmember 209. At this location, the second disc member 209 is able to moveupwards on the shaft 204, thereby engaging the drive dog 320 with thedrive notch 307 of the second test disc member 209. After the secondtest disc member 209 has moved upward by a distance equal to the heightof the spacer member 308, further upwards movement of the second testdisc member 209 is prevented by contact between the first guide member205 and the upper surface 303 of the second test disc member 209. Atthis point, which is shown in FIG. 12, the second guide member 206 islocated within the notch 301 of the first test disc member 208. Thisprevents further rotation of the first test disc member 208 within thecartridge 106.

By virtue of movement up the cartridge 106 of the first to third testdisc members 208 to 210, the third guide member 207 ceases to be withinthe notch 301 of the second test disc member 209. At this stage, thethird guide member 207 does not prevent rotational movement of thesecond disc member 209.

At the position shown in FIG. 12, the second test disc member 209 is inexactly the same position as was the first test disc member 208 at theposition shown in FIG. 6. Furthermore, the shaft 204, and thus the drivedog 320, has the same orientation. As such, the second test disc member209 is able to be used to elicit a blood sample from a user and test theglucose level thereof in the same way as was the first test disc member208.

By providing a stack of test disc members 208 to 210 within thecartridge 106 and by providing a suitable physical arrangement, acartridge 106 can be used for multiple tests. When the cartridge 106 isnew, the test disc members 208 to 210 are located in the bottom half ofthe cartridge 106, with the uppermost test disc member being alignedwith the aperture 105. As test disc members are used, the stack of testdisc members moves upwards in the cartridge. When the last test discmember is used, the cartridge can be said to be spent. At this stage,all of the test disc members are located in the uppermost portion of thecartridge 106.

It will be appreciated that the number of test disc members 208 to 210that can be accommodated within the cartridge 106, and thus the numberof tests that can be provided by a cartridge 106, is a factor of theheight of the cartridge 106, and the separation between correspondingparts (e.g. the upper surfaces) of adjacent test disc members 208 to210. A taller cartridge and/or a reduced separation of test disc membersincreases the number of tests that can be performed using a singlecartridge 106.

Reference will now be made to FIGS. 13 to 15, which illustrateconnection of the analyte measuring part 316 to measurement circuitry(not shown).

Referring firstly to FIG. 13, the hollow cylindrical housing part 203 isshown with the aperture 105 and the shaft 204 located as describedabove. A slit aperture 400 is provided in the hollow cylindrical housingpart 203. The slit aperture 400 is located at substantially the sameheight as the aperture 105. However, the slit aperture 400 is located ona side of the hollow cylindrical housing part 203 that is substantiallyopposite the aperture 105.

The slit aperture 400 does not coincide with the elongate aperture 110that is formed at the front side of the BGM 100. As such, the slitaperture 400 is not visible when the cartridge 106 is in place withinthe BGM 100.

FIG. 14 is the same view as shown in FIG. 13 although the hollowcylindrical housing part 203 is omitted.

Adjacent to the slit aperture 400 is located a swing arm 401. The swingarm 401 is rotatable about a spindle 402, as shown in FIG. 15. Thespindle 402 has an axis that is parallel to the axis of the shaft 204.The axis of the spindle 402 is located above the drive belt 202. Aconnecting arm 403 connects the spindle 402 to the swing arm 401. Inthis example, the connecting arm 403 is connected to the swing arm 401by a vertical connector 404. The vertical connector 404 allows thespindle 402 on which the connecting arm 403 is mounted to be located ata different vertical position to the swing arm 401. The spindle 402, theconnecting arm 403 and the vertical connector 404 are arranged such thatwhen the connecting arm is rotated on the axis of the spindle 402 theswing arm 401 is moved towards the shaft. The movement of the swing arm401 is substantially radial with respect to the shaft 204.

Mounted on the swing arm 401 are first to third electrical contactterminals 405. Each includes a generally horizontal arm 405 a and adepending contact head 405 b. The electrical contact terminals 405 aremade of a resilient conductive material, for instance metal. Thedepending contact heads 405 b are angled at their ends furthest from theswing arm 401.

In one position, shown in FIGS. 13 and 14, the electrical contactterminals 405 are supported by the swing arm 401 such that the dependentcontact heads 405 b are located within the slit aperture 400 oralternatively outside of the hollow cylindrical housing part 203. Whenthe test disc member 208 is rotated such that the blood collection part315 is coincident with the aperture 105, as shown in FIG. 14, thecontact pads 318 are coincident/aligned with the slit aperture 400. Asthe test disc member 208 is held in this position, the connecting arm403 is caused to rotate around the axis of the spindle 402 such that theswing arm 401 moves towards the shaft 204. The arrangement is such thatthe depending contact heads 405 b of the electrical contact terminals405, but not the horizontal arms 405 a, come into contact with thecontact pads 318 as the electrical contact terminals 405 move into thevolume above the upper surface 303 of the test disc member 208. Theresilient properties of the electrical contact terminals 405 causes theelectrical contact terminals to be forced against the contact pads 318.As such, an electrical connection is provided between the horizontalarms 405 a of the electrical contact terminals 405 and the analytemeasuring part 316. Electronic measuring means (not shown) connected tothe electrical contact terminals 405 operate to pass a voltage throughthe contact terminals 405 and the analyte measuring part 316 and to takemeasurements of electrical parameters, from which a measurement of ananalyte concentration level, for example a blood glucose level, can bedetermined.

The connecting arm 403 is controlled to remain in a position shown inFIG. 15 for a predetermined time or alternatively until it is detectedthat a blood glucose level measurement has been made, after which theconnecting arm 403 is caused to rotate around the shaft 402 so as toremove the electrical contact terminals 405 from the position above theupper surface of the test disc member 208. At this stage, thearrangement is as shown in FIG. 14. Once the electrical contactterminals 405 have been retracted, the test disc member 208 is rotatedanticlockwise so as to allow the test disc members 208 to 210 to moveupwards on the shaft 204.

It will be appreciated that the maximum permissible height dimension ofthe electrical contact terminals 405 is determined by the height of thespacer member 308. A thicker spacer member allows larger electricalcontact terminals 405 to be used. However, this is at the expense of anincrease in separation between adjacent test disc members 208 to 210,and thus a reduced capacity for the cartridge 106. The use of electricalcontact terminals 405 including a horizontal arm 405 a and a dependingcontact head 405 b allows the height dimension of the electrical contactterminals to be minimised whilst allowing good electrical contactbetween the electrical contact terminals and the contact pads 318 andalso allowing the electrical contact terminals 405 to operate correctlyover a sufficient number of cycles.

Referring now to FIGS. 16 to 21, an alternative arrangement is shownwith a novel lancing technique.

As shown in FIG. 16, the hollow cylindrical housing part 203 is providedwith the aperture 105 and the slit aperture 400. The shaft 204 issupported centrally within the hollow cylindrical housing part 203 ofthe cartridge 106. However, the diameter of the shaft is less than inthe embodiments described above.

A plunger arrangement 500 comprising a plunging arm 501 and a plunginghead 502 is provided adjacent a plunging aperture (not shown) in thehollow cylindrical housing part 203. The plunging aperture (not shown)is located next to the slit aperture 400. The plunging aperture (notshown) is located directly opposite to the aperture 105. The plungeraperture and the slit aperture 400 may be combined to form a singleaperture. The plunger aperture is configured to allow the plunging head502 to be forced by the plunging arm 501 to a position internal to thehollow cylindrical housing part 203.

Within the cartridge 106 are plural test disc members, one of which isshown as 505 in FIG. 17. Here, reference numerals are retained fromearlier described figures for like elements.

A lancet 506 is provided extending from the disc edge 305 in the cutawayportion 302. In particular, the lancet 506 extends in a radial directionwith respect to the centre of the test disc member 505. The lancet 506extends from a fourth position 507, which is near to the second position313. The fourth position 507 is further from the second position 313than is the corresponding first position 312 in the embodimentsdescribed above. However, because the lancet 506 is radial with respectto test disc member 505, a distal end 506 a of the lancet 506, i.e. theend that is furthest from the centre of the test disc member 505, is atapproximately the same position as the corresponding end of the lancet309.

The majority of the test disc member 505 is substantially rigid.However, an annular centre portion 508 is comprised of an elasticallydeformable material. In particular, the annular centre position 508 isdeformable in the presence of an externally applied force. This meansthat the test disc member 505 can be displaced relative to the shaft204, as will be described in more detail below. The material used toform the annular centre portion 508 may take any suitable form, and forinstance may be a rubberised plastic.

In FIG. 18, the hollow cylindrical housing part 203 is omitted from thefigure. In FIG. 18, the test disc member 505 is shown as having beenrotated to a position at which the lancet 506 is coincident with theaperture 105. It can be seen that the plunging head 502 is aligned withthe test disc member 505 such that movement of the plunger arrangement500 along the longitudinal axis of the plunging arm 501 causes theplunging head to contact the test disc member 505 and apply force to it.Since the longitudinal axis of the plunging arm 501 is radial withrespect to the shaft 204, the force applied by the plunger arrangementis directed towards the shaft 204.

In FIG. 19, the arrangement is shown after a force has been applied tothe plunger arrangement 500 so as to displace it by a predeterminedamount. Here, the plunging head 502 has contacted the test disc member505 on the opposite side of the test disc member to the lancet 506. Theannular centre portion 508 has become compressed on the side closest tothe plunger arrangement 500 such as to allow the whole of the test discmember 505 to be displaced in the direction of the force supplied by theplunger arrangement 500. The test disc member 505 remains horizontal byvirtue of the spacer members 308.

Displacement of the test disc member 505 in the direction of the forcesupplied by the plunger arrangement 500 has resulted in displacement ofthe lancet 506 in a radial direction away from the shaft 204. In thisposition, the lancet 506 penetrates the skin of the user's digit.Removal of the force by the plunger arrangement 500 allows the annularcentre portion 508 to return to its original form, through elasticreformation. After the plunger arrangement 500 has been fully retracted,the arrangement again has the form shown in FIG. 18. Here, the test discmember 505 is in its original position and the lancet 506 is retractedfrom the user's digit. It will be appreciated that it is the elasticityof the annular centre portion 508 of the test disc member 505 thatallows the test disc member 505 to return to this position once theforce applied through the plunger arrangement 500 is removed.

After removal of the force supplied by the plunger arrangement 500, thetest disc member 505 can be rotated by the drive wheel 201 and the drivebelt 202 so as to provide milking of the user's digit and thencollection of blood at the blood collection portion 315, which positionis shown in FIG. 20. After a measurement of blood glucose level istaken, the test disc member 505 is rotated further anticlockwise so thatthe second guide member 206 is aligned with the notch 301, and thus thetest disc member 505 is allowed to move upwards within the cartridge106. As a result, the test disc member 509 that is immediately below thefirst test disc member 505 also moves upwards within the cartridge 106and is provided to be coincident with the aperture 105, the slitaperture 400 and the plunger aperture (not shown). Subsequentapplication of a plunging force by the plunger arrangement 500 causes alancet 506 of the second test disc member 509 to be forced out of theaperture 105, as is shown in FIG. 21. The process can be repeated forother test disc members included in the cartridge 106.

An advantage of the arrangement shown in FIGS. 16 to 21 is that arotational arrangement can be used whilst allowing the lancet 506 topenetrate a user's skin in a longitudinal direction with respect to thelancet 506. Another advantage is that puncture can occur at any desiredlocation, for instance on the end of the user's digit, instead ofpuncturing occurring slightly on the side of the end of the digit.

Another advantage is that the arrangement can allow the penetrationdepth of the lancet 506 to be easily predictable.

Furthermore, it allows the penetration or puncturing depth to beadjustable. In particular, the adjustment of the penetration depth canbe achieved by a mechanical arrangement that limits movement of theplunger arrangement towards the shaft 204. Alternatively, it can beachieved in an electro-mechanical manner by measuring the location ordisplacement of some part of the mechanism and ceasing applying anenergising voltage to a solenoid or other transducer that is used toaffect movement of the plunger arrangement 500. Penetration depthcontrol is important to many users since lancet penetration usually ispainful and since penetration depth control allows users some controlover their experience.

An alternative form of test disc member 600 is shown in FIG. 22.Reference numerals are retained from above-described embodiments forlike elements.

The test disc member 600 differs from the test disc member 208 shown inFIG. 7 primarily by use of a curved lancet 601. The curved lancet 601protrudes from the disc edge 305 at a position 602 that is relativelyclose to a second position 313 at which the cutaway portion 302commences.

At the part of the curved lancet 601 that is adjacent the disc edge 305,the longitudinal axis of the curved lancet 601 is at an angle X withrespect to a straight line drawn between the junction between the curvedlancet 601 and the disc edge 305 and the centre of the shaft 204. Thecurve of the curved lancet 601 is such that the longitudinal axis of thecurved lancet at the end distant from the disc edge 305 is at an anglegreater than the angle X with respect to the line drawn between thejunction between the curved lancet 601 and the disc edge 305 and thecentre of the shaft 204. The effect is that the curved lancet 601 ismore aligned with the circumference of the test disc member 600 at itsdistal end than it is at the end that adjoins the disc edge 305. Thishas the positive effect that when the lancet penetrates a user's digit,or other body part, due to rotation of the test disc member 600, thepath taken by the lancet as it penetrates the user's digit more closelymatches the shape and orientation of the lancet than is experienced in acorresponding arrangement with a straight lancet.

This effect is enhanced with the lancet 601 since the cylindrical formof the lancet 601 is terminated at the distal end by an oblique cut. Inparticular, the distal end of the curved lancet 601 resembles a cylinderthat has been cut at an angle that is not perpendicular to thelongitudinal axis of the cylinder. As such, the end face of the curvedlancet 601 has the shape of an ellipse. The ellipse has a semi-majoraxis and a semi-minor axis and the point that is at the end of thesemi-major axis that is furthest from the disc edge 305 forms a point.The cut is made through the lancet 601 such that the point is formedextending in a direction that is substantially circumferential withrespect to the test disc member 600.

The configuration of the test disc members 208 to 210, 505, 600 is suchthat operation results in milking of the puncture in the user's digitcaused by the lancet 309. In particular, the aperture 105 is configuredsuch as to allow an amount of the flesh making up the end of the user'sdigit to be present within the internal volume of the cylindrical part203 when the user presses the digit up against the aperture 105. Whenthe user applies force into the aperture 105 with the digit, the digitdistorts and a bulbous part is provided within the internal diameter ofthe hollow cylindrical housing part 203. The size of the bulbous part,and in particular the height of the bulbous part, depends on a number offactors, including the physical characteristics of the user's digit andthe amount of force that the user applies, as well as the configurationof the aperture 105.

The aperture 105 is dimensioned such that in normal use (i.e. with atypical user applying a typical amount of force) a bulbous part of theuser's digit extends into the internal volume of the hollow cylindricalhousing part 203 to a depth of approximately 1 millimetre. The test discmembers 208 to 210, 505, 600 are configured to have a cutaway portion302 that is shaped such that when the lancet 309 is at a position atwhich it can lance the user's digit, the disc edge 305 is not in contactwith the user's digit (i.e. the separation between the disc edge 305 andthe aperture 105 is greater than 1 mm). This part of the cutaway portion302 can be termed a first milking portion. At this position, thepressure exerted by the user results in the fluid pressure within thebulbous part of their digit being slightly greater than normal pressure.The increased pressure results from the force the user applies to theirdigit. This pressure encourages bleeding of the puncture that is causedby the lancet 309. Advantageously, the arrangement of the relevantfeatures is such that the lancet 309 penetrates the user's digit to adepth of between 0.4 and 0.7 millimetres.

As the test disc member 208 to 210, 505, 600 then rotates anticlockwise,the lancet 309 is removed from the user's digit. A short timethereafter, the end of the bulbous part of the user's digit comes intocontact with the disc edge 305 at a position approximately one-third totwo-fifths of the way along the cut out portion 203. This part can betermed the second milking portion. The test disc member 208 to 210, 505,600 has a substantially constant radius for the second milking portion,which extends to a position approximately two-thirds or four-fifths ofthe way along the cutaway portion 302. For the time at which the secondmilking portion is coincident with the bulbous part of the user's digitas the test disc member 208 to 210, 505 rotates, the internal pressureof the bulbous part of the user's digit is increased compared to thetime at which the user's digit was in contact with the lancet 309.Furthermore, as the disc edge 305 moves into contact with and over thebulbous part of the digit, blood under the skin is caused to be pushedtowards the puncture caused by the lancet.

Between the second milking part and the location of the blood collectionpart 315, the radius of the test disc member 208 to 210, 505, 600 isreduced, or put another way has a lower value. This portion can betermed a third milking portion. As such, after the second milkingportion and before the user's digit contacts the blood collection part315, the pressure applied to the bulbous part of the user's digit by thedisc edge 305 is reduced compared to the pressure applied at the secondmilking portion. Advantageously, the radius of the test disc member 208to 210, 505, 600 at the third milking portion is selected such that thebulbous part of the user's digit does not contact the disc edge 305(i.e. the separation between the disc edge 305 and the aperture 105 isgreater than 1 mm). Whilst the third milking portion is coincident withthe user's digit as the test disc member 208 to 210, 505, 600 rotates,blood is free to exit the puncture made by the lancet 309. As the testdisc member 208 to 210, 505, 600 continues to rotate, the disc edge 305again contacts the bulbous part of the user's digit at a location justbefore the blood collection portion 315. This again increases theinternal pressure within the bulbous part of the user's digit. Thisencourages the movement of blood towards the analyte measuring part 316.The separation between the disc edge 305 at the location of the bloodcollection portion 315 and the aperture 105 is approximately 0.5 mm.

The configuration of the test disc members 208 to 210, 505, 600 thusencourages milking of a sample of blood from the user's digit. Thesequence is as follows: Firstly, lancing by the lancet 309 with arelatively low pressure (caused by no contact with the disc edge 305 andthe user's digit), followed by a period for which relatively low amountof pressure, as well as a rubbing movement, is provided by the secondmilking portion to the user's digit, followed by a period for whichlittle or no pressure is provided by the disc edge 305 against theuser's digit, followed by a relatively high pressure provided by thedisc edge 305 against the user's digit just before and at the bloodcollection part 315.

Operation of the blood glucose meter 100 will now be described withreference to the flowchart of FIG. 23. Operation starts at step S1. Atstep S2, the user locates their digit in the aperture 105. As mentionedabove, the user forces their digit into the aperture 105 with a pressureor force that is suitable to allow lancing and blood collection. At stepS3, the user initiates blood glucose measurement. This involves the userpressing one of the inputs 101 to 103. This is detected by themicroprocessor 212 by way of the keys interface 215. Thesoftware/firmware stored in the ROM 214 uses the key input to call afunction or to execute a software module. The software/firmware storedin the ROM 214 then causes the microprocessor 212 to issue a command toa motor attached to the drive wheel 201 through the motor interface 217to rotate the shaft 204 in a first direction, for example in a clockwisedirection. The software/firmware controls the extent of the rotation. Atstep S4, the amount of rotation is sufficient to lance the user's digitwith the lancet 309. The software/firmware stored in the ROM 214 thencauses the microprocessor 212 to control the motor to rotate the shaft204 in the opposite direction, at step S5. As the test disc memberrotates in the opposite direction, for example anticlockwise, milkingoccurs at step S6. Firstly, at step S6A, there is no pressure applied bythe test disc member on the digit. At step S6B, there is a medium amountof pressure on the digit. At step S6C, there is low or no pressureapplied by the test disc member on the digit. At this point, the digitcoincides with the part of the test disc member that is immediatelybefore the blood collection part 315.

At step S7, the software/firmware causes the microprocessor 212 tocontrol the motor to cease rotation when the shaft 214 is such that theblood collection member 315 is coincident with the aperture 105, andthus the user's digit. At step S8, the software/firmware controls amotor such as to cause the swing arm 401 to be rotated towards the shaft204. The software/firmware stored in the ROM 214 is such that themicroprocessor 212 causes only the required amount of travel of theswing arm 401. At this point, the analyte interface circuit 219 iscoupled directly to the blood analyte measuring part 316, which byaction of the blood collection part 315 has been provided with bloodfrom the user's digit. At step S9, analyte measurement is performed.This involves the analyte interface circuit 219 providing voltages tothe electrical connection contacts 318, and thus to the blood analytemeasuring part 316, and measuring parameters of resulting signals. Themeasured parameters, particularly voltage parameters, are used by thesoftware/firmware stored in the ROM 214, as executed by the processor212, to calculate a blood glucose measurement level of the user. Theblood glucose measurement is then caused by the software/firmware to bedisplayed on the display 104 through action of the microprocessor 212 onthe display drive 216. At step S10, the swing arm is caused to beremoved by action of the microprocessor 212, under control of thesoftware stored in the ROM 214, the motor interface 217 and the motor(not shown).

At step S11, the software/firmware results in the microprocessor 212controlling the drive disc 201 to rotate in the opposite direction.Rotation continues until the notch 301 on the test disc member iscoincident with the guide 206. At step S12, the test disc member risesup the cartridge 106. In the case where biasing of the test discs up thecartridge 106 is provided by a bias means, for instance a spring, stepS12 requires no action on part of the software/firmware andmicroprocessor 212, although there may be a pause before the next step.In embodiments where movement of the test disc members along the shaft204 occurs through driving action, step S12 involves the microprocessor212, under control of the software/firmware stored in the ROM 214,controlling a motor through the motor interface 217. Subsequently, atstep S13, the microprocessor 212, under control of the software/firmwarestored in the ROM 214, causes the shaft 204 to rotate again in the firstdirection and to cease rotating when the drive dog 320 engages with thedrive slot 307 of the next test disc member in the cartridge 106. Atthis stage, the test disc members rise up the cartridge 106 slightly.

The operation ends at step S14.

FIG. 24 illustrates operation of the blood glucose meter 100 asdescribed with reference to FIGS. 16 to 21.

Operation starts at step T1. At step T2, the user locates their digit inthe aperture 105. As mentioned above, the user forces their digit intothe aperture 105 with a pressure or force that is suitable to allowlancing and blood collection. At step T3, the user initiates bloodglucose measurement. This involves the user pressing one of the inputs101 to 103. This is detected by the microprocessor 212 by way of thekeys interface 215. The software/firmware stored in the ROM 214 uses thekey input to call a function or to execute a software module. Thesoftware/firmware stored in the ROM 214 then causes the microprocessor212 to issue a command to a motor attached to the drive wheel 201through the motor interface 217 to rotate the shaft 204 in a firstdirection, for example in a clockwise direction. The software/firmwarecontrols the extent of the rotation.

Following step T3, the microprocessor 212, under control of thesoftware/firmware stored in the ROM 214, causes the shaft 204 to berotated by a motor through the motor interface 217 and to cease rotationonce the lancet 508 is aligned with the aperture 105, and thus isaligned with the user's digit, at step T4A. At step T4B, themicroprocessor 212, under control of the software/firmware stored in theROM 214, causes actuation of the plunger arrangement 500, through themotor interface 217. The control of the actuation of the plunger is suchas to limit the extent of movement of the lancet 508 to a predeterminedextent. The predetermined extent is set by a user through operation ofthe keys 102, 103 prior to the blood glucose measurement. In effect, theuser can use the keys 102, 103 to set a lancing depth, which is storedin a suitable way in the ROM 214 by action of the microprocessor 212,operating under control of the software/firmware stored in the ROM 214.

When the maximum extent of plunger actuation has been reached at stepT4B, at step T4C the plunger arrangement 500 is deactuated by themicroprocessor 212, under control of the software/firmware stored in theROM 214, and lancing ceases. At this step, the test disc member returnsto its original position by action of the elasticity of the annularcentre portion 508 of the test disc member 508.

Although in the figures, an in particular in FIG. 7, three conductivetracks 317 and three conductive pads 318 are shown, it will beappreciated that this is merely illustrative. There may instead be onlytwo conductive tracks 317 and two conductive pads 318, or alternativelythere may be more than three conductive tracks and conductive pads.

The software/firmware stored in the ROM 214 then causes themicroprocessor 212 to control the motor to rotate the shaft 204 in theopposite direction, at step T5. As the test disc member rotates in theopposite direction, milking occurs at step T6. Firstly, at step T6A,there is no pressure applied by the test disc member on the digit. Atstep T6B, there is a medium amount of pressure on the digit. At stepT6C, there is low or no pressure applied by the test disc member on thedigit. At this point, the digit coincides with the part of the test discmember that is immediately before the blood collection part 315.

At step T7, the software/firmware causes the microprocessor 212 tocontrol the motor to cease rotation when the shaft 214 is such that theblood collection member 315 is coincident with the aperture 105, andthus the user's digit. At step T8, the software/firmware controls amotor such as to cause the swing arm 401 to be rotated towards the shaft204. The software/firmware stored in the ROM 214 is such that themicroprocessor 212 causes only the required amount of travel of theswing arm 401. At this point, the analyte interface circuit 219 iscoupled directly to the blood analyte measuring part 316, which byaction of the blood collection part 315 has been provided with bloodfrom the user's digit. At step T9, analyte measurement is performed.This involves the analyte interface circuit 219 providing voltages tothe electrical connection contacts 318, and thus to the blood analytemeasuring part 316, and measuring parameters of resulting signals. Themeasured parameters, particularly voltage parameters, are used by thesoftware/firmware stored in the ROM 214, as executed by the processor212, to calculate a blood glucose measurement level of the user. Theblood glucose measurement is then caused by the software/firmware to bedisplayed on the display 104 through action of the microprocessor 212 onthe display drive 216. At step T10, the swing arm is caused to beremoved by action of the microprocessor 212, under control of thesoftware stored in the ROM 214, the motor interface 217 and the motor(not shown).

At step T11, the software/firmware results in the microprocessor 212controlling the drive disc 201 to rotate in the opposite direction.Rotation continues until the notch 301 on the test disc member iscoincident with the guide 206. At step T12, the test disc member risesup the cartridge 106. In the case where biasing of the test discs up thecartridge 106 is provided by a bias means, for instance a spring, stepT12 requires no action on part of the software/firmware andmicroprocessor 212, although there may be a pause before the next step.In embodiments where movement of the test disc members along the shaft204 occurs through driving action, step T12 involves the microprocessor212, under control of the software/firmware stored in the ROM 214,controlling a motor through the motor interface 217. Subsequently, atstep T13, the microprocessor 212, under control of the software/firmwarestored in the ROM 214, causes the shaft 204 to rotate again in the firstdirection and to cease rotating when the drive dog 320 engages with thedrive slot 307 of the next test disc member in the cartridge 106. Atthis stage, the test disc members rise up the cartridge 106 slightly.

The operation ends at step T14.

Various modifications and alternative features can be used in connectionwith the above-described embodiments. Some alternatives now follow.

Instead of the blood collection part 315 being located next to the thirdposition 314, i.e. bounding only the part of the disc edge 305 that ispurely circumferential, the blood collection part could instead belocated on the disc edge 305 at the junction between the cutaway portion302 and the circumferential portion. The blood collection 315 part inthis instance may extend for between 0.5 mm and 2 mm along the disc edge305 at the cutaway portion 302. The blood collection 315 part in thisinstance may also extend for between 0.5 mm and 2 mm along the disc edge305 at the circumferential part.

Alternatively or additionally, the analyte measuring part 316 may besandwiched between two layers of wicking material, the wicking materialcausing the blood to be drawn through the analyte measuring part 316.

Although in the above the shaft 204 is said to be driven by a drivewheel 201 that is coupled to the shaft 204 by a drive belt 202, thedrive may instead be direct (i.e. the drive mechanism is coupleddirectly to the shaft 204), or connection may be made by a notched belt,a vee belt, or by a direct gear mechanism. Instead of an electric motor,a clockwork drive could be used. A clockwork drive mechanism has anumber of advantages, particularly where access to batteries or batterychargers or electricity supplies are limited. In the embodiments inwhich a clockwork mechanism is used, the user can be sure that the BGM100 will not cease operating because of drained batteries. A clockworkmechanism may be particularly suited to developing countries andemerging markets.

In embodiments in which an electrical motor is used to drive the shaft204, preferably control is exerted over the motor by software. In thisway, the speed of rotation can easily be controlled. Additionally, theextent of rotation can more easily be controlled. The motor may be astepper motor.

Alternatively, a mechanical drive arrangement may be present, forinstance using a lever or other device for manual actuation. A suitablemechanism may be one similar to those previously used in SLR cameras.

The swing arm 401 may be actuated in any suitable way. For instance, itmay be driven by the same motor or mechanism as the shaft 204.Alternatively, it may be driven by a separate motor. In either case, therotation of the swing arm 404 may be affected by a cam mechanism, or bya pin and slot (track path) mechanism. In the event of an electric motorbeing used, the motor preferably is software driven. The motorpreferably is a stepper motor.

The mechanical arrangement may include a mechanism by which a biasmeans, for instance a mechanical compression spring, is biased and thenreleased in order to push the electrical contact terminals 405 intoplace. The terminals 405 can then be retracted by the swing arm 401using a rotating motion. The overall mechanism can be termed a latchtype trigger mechanism.

Instead of a swing arm 401 being used to rotate the electrical contactterminals 405 into place, the contact pads 318 may instead be located onthe disc edge 305, allowing the use of fixed electrical contactterminals 405. The electrical contact terminals may include a brush orother deformable feature such that the test disc members 208 to 210,505, 600 can move whilst in contact with the electrical contactterminals without damage occurring to any of the components. Similararrangements are used in brushed DC motors. In this case the electricalcontact terminals 405 could be flexible finger contacts that rest on theperiphery of the test disc members 208 to 210, 505, 600 in order tocontact the contact pads 318.

Alternatively, instead of a swing arm 401, a mechanism may be used toaffect longitudinal movement of the electrical contact terminals 405into place to contact the contact pads 318.

The conductive tracks 317 and the contact pads 318 may be formed byleadframe. Alternatively, overmoulding may be used. Alternatively,printed circuit board (PCB) printing may be used.

Optionally, each of the test disc members 209, 210, 505, 600 isseparated from adjacent test disc members by a membrane (not shown inthe drawings). In this case, the membrane preferably fits closely to theinternal surface of the hollow cylindrical housing part 203. An effectof the membrane is to reduce the possibility of disccross-contamination. Use of a membrane may allow the test disc members208 to 210, 505, 600 to have a reduced separation than would be the casewithout the use of a membrane.

In the above, the test disc members 208 to 210, 505, 600 are said to bebiased upwards by a bias means, for instance a compression spring.Alternative mechanisms for moving the test disc members 208 to 210, 505,600 up the cartridge may be used. For instance, a threaded lifting cammay be provided on the shaft 204 or alternatively on the interiorsurface of the hollow cylindrical housing part 203. Alternatively, thetest disc members 208 to 210, 505, 600 may remain stationary, with theaperture 105 and the drive dog 320 instead being moved along the axis ofthe cartridge 106. Movement of the aperture 105 may be achieved by theuse of a sliding door in an elongated slot. Movement of the door allowsa different strip to be revealed at the aperture 105.

Instead of the blood collection portion 315 wicking blood towards theanalyte measuring part 316, blood may be communicated to the analytemeasuring part 316 instead through gravity.

Additionally, the test disc members 208 to 210, 505, 600 may include adisinfecting or cleaning portion that contacts the digit before lancing.This can reduce risk of infection of the wound and also can increaseaccuracy in particular by removing any glucose from the skin (as mayoccur after eating fruit etc.).

Additionally or alternatively, the test disc members 208 to 210, 505,600 may include a cleaning portion that is arranged to contact the digitsubsequent to the blood collection part 305. This can remove additionalblood from the finger, and may also serve to assist closure of thepuncture.

The invention claimed is:
 1. Apparatus for eliciting a blood sample, theapparatus comprising: a housing; a shaft mounted within the housing; anaperture in the housing, the aperture being configured to receive a partof a user; a member rotatably mounted on the shaft; a lancet protrudingfrom one position at an edge of the member, a blood collection partlocated at a second, different position at the edge of the member,wherein the apparatus is configured such that: when the member is in afirst rotational position the lancet is shielded by the housing, whenthe member is in a second rotational position the lancet is operable tolance the part of the user received at the aperture, and when the memberis in a third rotational position the blood collection part is presentedsuch as to receive blood from the part of the user received at theaperture.
 2. Apparatus according to claim 1, wherein the member furthercomprises at least two electrical contact points connected to the bloodcollection part for communication with a meter for determining aparameter of blood chemistry.
 3. Apparatus as claimed in claim 1,wherein the blood collection part includes a wicking or absorbent partand an analyte measurement part.
 4. Apparatus according to claim 1,wherein the apparatus is configured to maintain the member at the thirdrotational position until it is determined that a quantity of bloodcollected at the blood collection part is sufficient to allow a bloodchemistry measurement to be made.
 5. Apparatus according to claim 1,wherein the member is provided with a milking part between the first andsecond locations on the edge of the member.
 6. A method of eliciting ablood sample, the method comprising: providing a housing, a shaftmounted within the housing, an aperture in the housing, the aperturebeing configured to receive a part of a user, a member rotatably mountedon the shaft, a lancet protruding from one position at an edge of themember, and a blood collection part located at a second, differentposition at the edge of the disc-like member; commencing in a firstrotational position in which the lancet is shielded by the housing;rotating the member to a second rotational position in which the lancetis operable to lance the part of the user received at the aperture; androtating the member to a third rotational position in which the bloodcollection part is presented such as to receive blood from the part ofthe user received at the aperture.
 7. A method according to claim 6wherein the member further comprises at least two electrical contactpoints connected to the blood collection part for communication with ameter for determining a parameter of blood chemistry.
 8. A methodaccording to claim 6, wherein the blood collection part includes awicking or absorbent part and an analyte measurement part.
 9. A methodaccording to claim 6, comprising maintaining the member at the thirdrotational position until it is determined that a quantity of bloodcollected at the blood collection part is sufficient to allow a bloodchemistry measurement to be made.
 10. A method according to claim 6,comprising milking the part of the user as the member rotates betweenthe second and third rotational positions.
 11. Apparatus comprising: ahousing; a shaft, the shaft being mounted within the housing; anaperture, the aperture being located in the housing, the aperture beingconfigured to receive a part of a user; at least one member, each ofsaid at least one member being mounted on the shaft so as to berotatable thereon, and wherein each of said at least one member:includes an edge; includes a lancet, the lancet being arranged toprotrude from a first position at said edge of said at least one member;and includes a blood collection part, the blood collection part beinglocated at a second position at said edge of said member, wherein theapparatus is configured such that: when the member is in a firstrotational position, the lancet is separated from the aperture so as tobe shielded by the housing, when the member is in a second rotationalposition, the lancet is operable to lance the part of the user receivedat the aperture, and when the member is in a third rotational position,the blood collection part is presented such as to receive blood from thepart of the user received at the aperture.
 12. Apparatus according toclaim 11, wherein the member further comprises at least two electricalcontact points connected to the blood collection part, for coupling to ameter such as to allow determination of a parameter of blood chemistrythereby.
 13. Apparatus as claimed in claim 11, wherein the bloodcollection part comprises an analyte measurement part and one of: a) awicking part, and b) an absorbent part.
 14. Apparatus according to claim11, wherein the apparatus is configured to maintain the member at thethird rotational position and, in response to a determination that aquantity of blood collected at the blood collection part is sufficientto allow a blood chemistry measurement to be made, further to rotate themember.
 15. Apparatus according to claim 11, wherein the member isprovided with a milking part between the first position and the secondposition on the edge of the member.